# FDA recall Z-1890-2018

> **ConvaTec, Inc** · Class II · device recall initiated 2018-04-25.

## Product

Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475    Product Usage:  Esteem Synergy Stomahesive with Flexible Collar 22mm Precut Skin Barrier is used together with Esteem Synergy pouches as an ostomy system intended for the management of stomal output.

## Reason for recall

It was discovered that the stoma hole of one lots of the Esteem synergy Stomahesive Skin Barrier wafers is larger that the 7/8 inch / 22mm specified on the box label.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-1890-2018
- **Recalling firm:** ConvaTec, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-25
- **Report date:** 2018-05-23
- **Termination date:** 2023-02-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Greensboro, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1890-2018

## Citation

> AI Analytics. FDA recall Z-1890-2018. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1890-2018. Source: US FDA. Licensed CC0.

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